Clinical trial · Interventional
FAPI PET/CT for Lymph Node Staging in Colorectal Carcinoma
Pilot Study of FAPI PET/CT for Locoregional (re)Staging of Lymph Nodes in Colorectal Carcinoma
NCT05209750CI-TRIAL-00069817FAPI-CRC1unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To describe the accuracy of FAPI PET/CT in the detection of regional lymph node metastases in patients with colorectal cancer in comparison with standard diagnostic imaging and (in operated patients) histopathology, aiming to provide early evidence of the diagnostic value of FAPI PET/CT.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FAPI PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FAPI PET/CT
- description
- Colon cancer patients: one FAPI PET/CT scan early after standard diagnostic imaging and prior to planned surgery. Rectal cancer patients: two FAPI PET/CT scans, one for initial staging (pre neoadjuvant therapy) and one for restaging (post neoadjuvant therapy).
- interventionNames
- Diagnostic Test: FAPI PET/CT
Primary outcomes (3)
- measure
- Presence of lymph node metastases on FAPI PET/CT
- timeFrame
- <4 weeks from diagnosis for colon cancer and 10-17 weeks from diagnosis for rectal cancer
- description
- Comparison: diagnostic contrast enhanced CT abdomen for colon cancer patients and diagnostic MRI for rectal cancer patients. Reference test: histopathology after surgery.
- measure
- Number of positive regional lymph nodes (count)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy proven newly detected adenocarcinoma of the colon or rectum * cTany N1-2 Many using TNM 8th edition and based on standard diagnostic imaging including contrast enhanced-CT thorax-abdomen (for colon and rectum) and pelvic MRI (for rectum) * Indication for curative local treatment of the primary colon/rectal tumour * Signed written informed consent prior to any study specific procedure For colon cancer patients: * Age \> 18 years * Indication for surgery including resection of the colon tumour and the corresponding mesentery * Surgery can be planned within 5 weeks after diagnostic imaging * Surgery takes place in one of the participating centres of this study For rectal cancer patients: * Age \> 50 years and older * Indication for neoadjuvant (chemo)radiotherapy of the rectal tumour * Planned for response assessment after (chemo)radiotherapy with pelvic MRI * Planned for surgery or an organ preservation approach in one of the participating centres of this study \* Related to the allowed radiation dose per age category for diagnostic imaging and in accordance with the guideline of the Dutch Commission for Radiation Dosimetry (NCS). Exclusion Criteria: * Inability to provide informed consent * Histopathology of mucinous adenocarcinoma * WHO \> 2 * Pregnancy * Lactation, unable to substitute for 24 hours after FAPI PET/CT * Known second malignant disease that may complicate image interpretation including a second primary at time of colorectal cancer diagnosis * Inability to cooperate with the scan process: inability to lie relatively still and in supine for 30-60 minutes or patient body habitus above scanner dimensions * Suspicion of peritoneal metastases based on contrast-enhanced CT and/or MRI * Treatment setting without local treatment of the primary colorectal tumour For colon cancer patients: * Absence of diagnostic contrast enhanced-CT thorax-abdomen * Refusal of surgery by the patient * Indication for neoadjuvant treatment * Indication for emergency surgery For rectal cancer patients: * Contra-indication for MRI * Absence of diagnostic pelvic MRI and/or contrast enhanced-CT thorax-abdomen * Refusal of neoadjuvant treatment by the patient * Absence of response assessment after (chemo)radiotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.